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Clinical chemistry analysis is one of the most important areas within clinical laboratory analysis. The term clinical chemistry usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily-collected bodily fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations. The analysis of virtually any biologically-active substance--any place in the body--can loosely be defined as clinical chemistry. In fact, traditional specialization barriers such as microbiology, hematology, blood banking, immunology and even anatomical pathology are rapidly fading, both operationally and instrumentally. But for the sake of defining the subject to a reasonable size, the more traditional scope of clinical chemistry will be the subject of this TriMark Publications study. The purpose of this report is to describe the specific segments of the global clinical chemistry instrumentation market. Specifically, this study examines the markets for small lab and highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers original equipment manufacturer (OEM) additional equipment. The emphasis is on those companies and products that are actively developing and marketing chemistry analyzer products for the clinical setting, including hospitals, independent labs, physicians offices and clinics. Concentration is on the clinical chemistry instrumentation industry market segment in the U.S. and around the world. Particular attention is paid to those areas of the clinical chemistry instrumentation sector that are showing the greatest growth or the most innovation.

Table of Contents :

1. Overview 5

1.1 Objectives of the Report 5

1.2 Methodology 5

1.3 Scope of the Report 7

1.4 Executive Summary 7

2. IVD Clinical Chemistry Market 9

2.1 Introduction 9

3. IVD Clinical Chemistry Market 11

3.1 Markets 11

3.1.1 Global Markets 11

3.1.2 Global Drivers of Clinical Chemistry Testing 13

3.1.3 Global Outlook 14

3.1.4 U.S. Market 14

3.1.5 European Market 16

3.1.5.1 German Clinical Chemistry Diagnostic Markets 19

3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market 21

3.1.5.2.1 U.K. Market Statistics 21

3.1.5.2.2 U.K. Competitive Analysis 22

3.1.5.2.3 U.K. Market Access 23

3.1.5.3 French Clinical Chemistry Diagnostic Market 23

3.1.5.4 Italian Clinical Chemistry Diagnostic Market 24

3.1.5.5 Spanish Clinical Chemistry Diagnostic Market 24

3.1.5.6 Indian Clinical Chemistry Diagnostic Market 25

3.1.5.6.1 Indias In Vitro Diagnostic Testing Industry 25

3.1.5.7 Scandinavian Clinical Chemistry Market 27

3.1.5.8 Japanese Clinical Chemistry Testing Market 27

3.1.5.9 Country Clinical Chemistry Smaller Markets 28

3.1.5.9.1 Chinese Clinical Chemistry Market 28

3.1.5.9.2 Canada Clinical Chemistry Market 31

3.1.5.9.3 Brazil Clinical Chemistry Market 32

3.1.5.9.4 Turkey Clinical Chemistry Market 33

3.1.5.9.5 Australia Clinical Chemistry Market 33

3.1.5.9.6 Mexico IVD Market 33

3.1.5.10 Remaining World Clinical Chemistry Testing Market 34

3.1.5.11 Overview of Asian Healthcare Market 35

3.1.5.11.1 Singapore 35

3.1.5.11.2 Malaysia 35

3.1.5.11.3 Thailand 35

3.1.5.11.4 Indonesia 36

3.1.5.11.5 Philippines 36

3.1.5.11.6 South Korea 36

3.1.5.11.7 India 37

3.1.5.11.8 Hong Kong 37

3.1.5.11.9 Taiwan 37

3.1.5.12 Overview of the Latin American Diagnostics Market 37

3.2 Clinical Chemistry Sector 38

3.2.1 Industry-Served Markets 38

3.2.2 Industry Players 38

3.2.2.1 Manufacturing Companies 38

3.2.3 Market Specialization 39

3.2.4 Revenue and Reimbursement 41

3.2.5 Companies 41

3.3 Outlook for Clinical Chemistry Testing 42

3.3.1 Long-Term Changes 42

3.3.2 Market Drivers 44

3.3.3 The Limits to Growth 44

3.3.4 Hot Sectors in the IVD Market 44

3.3.5 Key Technologies 45

3.3.6 Conclusion 45

4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors 46

4.1 Ultra-Large Throughput Chemistry Analyzers 46

4.2 Large-Throughput Analyzers 61

4.3 Mid-Size Clinical Chemistry Analyzers 73

4.4 Chemistry Analyzers for the Small-Volume Market 78

5. Important Technology Trends 81

5.1 Technology Platform Innovations in Point-of-Care Testing 81

5.2 Sensor Systems for Diagnostic Applications 81

5.3 Glucose Measurements 83

5.4 Glucose Test Methods 86

5.5 Cholesterol Measurements 86

5.6 The New Paradigm 87

5.7 Consolidated Workstations 87

5.8 Automation in the Laboratory in Response to Labor Shortages 89

5.9 Laboratory Information Systems 90

5.10 Biosensor Technology 91

5.11 Data-Management Issues 92

5.11.1 Wireless LANs 93

5.11.2 Data and Workflow Management Systems 93

5.11.3 Beckman Command Central Version 2.0 94

5.12 Connectivity Platforms 94

5.12.1 Laboratory Data Linking Software and Interface to the Laboratory Information System 94

5.12.2 AbbottLink Analyzer Connections 95

5.12.3 Beckman Coulter DL2000 Data Manager v6.5 95

5.12.4 bioMrieux Inc. ENQ 95

6. Business Trends in the Clinical Chemistry Analyzer Sector 97

6.1 Key Developments 97

6.2 Sector Consolidation 97

6.3 Diagnostic Testing Growth Trends 98

6.4 Reagent and Hardware Business in Japan 99

6.5 New Products 99

6.6 Acquisition, License Agreements, Internal Development and Partnerships 99

6.7 Product Testing Depth in Clinical Chemistry Testing 100

6.8 Government Regulation 100

6.8.1 U.S. Regulation 100

6.8.1.1 Importing Medical Devices to the U.S. 102

6.8.1.2 Exporting Medical Devices from the U.S. 102

6.8.2 U.K. Regulation 103

6.8.3 E.U. Regulation 104

6.8.4 Japanese Regulation 105

6.8.5 Korean Regulation 106

6.9 Increased Market Penetration 106

6.10 Costs of Doing Business in Europe 108

6.11 Drivers of European Diagnostics Testing 108

6.12 European Reimbursement Practices 108

6.13 Cost Containment in Europe 108

6.14 Medicare Reimbursement Trends 108

7. Company Profiles 112

7.1 Abaxis, Inc. 112

7.2 Abbott Diagnostics 114

7.3 Adaltis Inc. 122

7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 122

7.5 Awareness Technology, Inc. 123

7.6 Siemens Medical Solutions USA, Inc. 123

7.7 Beckman Coulter, Inc. 124

7.8 Dade Behring, Inc. (Acquired by Siemens Medical Solutions) 129

7.9 Hitachi, Ltd. 135

7.10 Horiba, Ltd. 136

7.11 JEOL Ltd. 136

7.12 Nova Biomedical Corporation 137

7.13 Olympus America, Inc. 138

7.14 Ortho-Clinical Diagnostics, Inc. 139

7.15 Roche Diagnostics Corp. 141

7.16 Shimadzu Corporation 143

7.17 Sysmex Corporation 143

7.18 Thermo Fisher Scientific Inc. 144

7.19 Vital Scientific B.V. 145

8. Clinical Chemistry Testing Sector Trends and Forecasts 147

8.1 Home Care Analysis 147

8.2 Non-traditional Collection for Chemistry Testing 147

8.3 New Systems for Critical-Care and Near-Patient Testing 147

8.4 Utility of Near-Patient Testing in Critical-Care Settings 147

8.5 Mergers of Diagnostic Companies 147

8.6 Information Management Advances 147

8.7 Test Ordering Patterns 147

8.8 Patient Satisfaction 147

8.9 Move Away From Central Laboratory 148

8.10 Healthcare Cost Controls 148

8.11 Competition for Services 148

8.12 Drivers of Clinical Chemistry Testing 148

8.13 Confluence of New Technology 148

8.14 New Trends in Clinical Laboratory Testing 149

8.14.1 Trends in Reimbursement Practices 149

8.14.2 Managed Care 151

8.14.3 Changes in Patient Management 152

8.14.4 Focused Testing 152

8.14.5 Satellite Facilities 152

8.14.6 Point-of-Care Testing 152

8.14.7 Regionalization of Laboratory Care 153

8.15 New Chemistry Analyzers 154

8.16 Multiplexing Technology 154

9. Clinical Chemistry Product Introductions 156

9.1 Clinical Chemistry Analyzer Product Launches 156

9.2 Clinical Chemistry Reagent Product Launches 156

10. Corporate Directory 157

INDEX OF FIGURES

Figure 3.1: 17

Figure 6.1: 109

LIST OF TABLES

Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide, 2008 11

Table 3.2: Worldwide Distribution of IVD Testing, 2008 11

Table 3.3: Global Clinical Chemistry Revenues, 1998-2012 12

Table 3.4: Worldwide Distribution of Clinical Chemistry Testing, 2006 12

Table 3.5: Thirteen Largest Diagnostic Companies Worldwide, 2007 12

Table 3.6: U.S. Clinical Chemistry Testing Market, 2000-2012 15

Table 3.7: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2008 15

Table 3.8: U.S. Individual Clinical Chemistry Diagnostic Test Markets, 2007 16

Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 16

Table 3.10: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 17

Table 3.11: European Clinical Chemistry Testing Market, 2000-2008 18

Table 3.12: European Rapid Point of Care Testing by Country Market Estimates, 2008 19

Table 3.13: German Clinical Chemistry Testing Diagnostics Products Market Sales, 2003-2012 20

Table 3.14: The German Patient Care Lab Test Market, 2000-2008 20

Table 3.15: The German Alternate Site Testing Market (POL), 2000-2008 20

Table 3.16: The German Hospital Clinical Chemistry Market, 2000-2008 20

Table 3.17: U.K. Clinical Chemistry Diagnostics Products Market Sales, 2000-2008 22

Table 3.18: Major U.K. IVD Manufacturers 22

Table 3.19: U.S. IVD Manufacturers Doing Business in the U.K. 23

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